MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION CX; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2317-50

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/11/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing inadequate stimulation due to lead migration.The patient underwent a lead and clik anchor replacement procedure and was doing well postoperatively.The explanted leads were not returned as they were kept by the facility.

Manufacturer Narrative

Block b3: exact date unknown, event occurred a couple of months ago.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2317-50, serial: (b)(4), batch: 7075732.Product family: scs-lead fixation, upn: (b)(4), model: sc-4318, batch: 26073908.

• Brand Name: INFINION CX
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15712411
• MDR Text Key: 302826650
• Report Number: 3006630150-2022-05897
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: 08714729861614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2022
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7073556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female